Nasal saline irrigation with azelastine-fluticasone nasal spray in
moderate-to-severe persistent allergic rhinitis: a randomized controlled trial
#MMPMID41158297
Li S
; Xu R
; Yu S
; Wang M
; Fan J
; Chen M
; Gong X
; Gu Q
; Chen F
; Jin L
; Geng C
; Yan M
; Qiu C
; Lu M
; Cheng L
Front Allergy
2025[]; 6
(?): 1622510
PMID41158297
show ga
BACKGROUND: Symptom control in patients with moderate-to-severe persistent
allergic rhinitis (PAR) who remain inadequately controlled on intranasal
corticosteroid monotherapy remains challenging, highlighting the urgent need for
more effective treatments. This study aimed to determine whether the addition of
nasal saline irrigation to a regimen of intranasal corticosteroids and
antihistamines can further improve symptoms in patients with moderate-to-severe
PAR. METHODS: A multicenter, randomized, open-label, controlled trial was
conducted, enrolling 248 eligible patients aged 12 years and above from six
clinical centers. They were randomized 1:1 into two groups. The experimental
group received nasal saline irrigation combined with azelastine-fluticasone
(Aze-Flu) nasal spray, and the control group was treated with azelastine nasal
spray and fluticasone nasal spray. The primary outcome was the least-squares-mean
(LSmean) change in total nasal symptom score (TNSS) from baseline to four weeks,
with secondary outcomes including LSmean change in TNSS from baseline to two
weeks, subscores, rhinoscopic scores, visual analogue scale (VAS), and
rhinoconjunctivitis quality of life questionnaire (RQLQ) scores. RESULTS: Both
groups exhibited significant reductions in TNSSs from baseline (p?0.001). In
comparison to the control group, the experimental group exhibited greater LSmean
changes in TNSS scores following either two or four weeks of treatment (p?0.001
at both time points). The experimental group presented more favorable changes in
rhinoscopy scores, VAS scores, and RQLQ scores. Both groups showed no substantial
differences in adverse events, indicating a comparable safety profile.
CONCLUSION: Nasal saline irrigation combined with Aze-Flu nasal spray provides
additional benefits in managing moderate-to-severe PAR, with good safety and
tolerability. This combination therapy could be a valuable option in primary care
settings. CLINICAL TRIAL REGISTRATION: http://www.medicalresearch.org.cn,
identifier (MR-32-23-044661).